By Chilton Davis Varner, Senior Counsel, and Franklin Sacha, an Associate, with King & Spalding LLP in the firm’s Atlanta, GA office.
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A New Jersey appellate court recently issued a decision that may assist medical device manufacturers in submitting certain FDA evidence at trial, thereby leveling the playing field in product liability suits involving medical devices. Hrymoc v. Ethicon, Inc., No. A-1083-18, 2021 WL 787039 (N.J. Super. Ct. App. Div. Mar. 2, 2021). In Hrymoc, which was consolidated for purposes of appeal with a related case (McGinnis), the appellate court held that the trial courts erred by “categorically excluding” any proof that the defendants obtained FDA clearance to market their surgical mesh devices. Id. at *1. The appellate court’s holding is significant because several courts have affirmed the exclusion of such evidence from trial. This recent decision helps push the body of caselaw in the direction of admitting this evidence in medical device cases. Predictably, the plaintiffs promptly sought review by the Supreme Court of New Jersey.
The Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act (“FDCA”) establish three categories for medical devices. Class I devices are subject to general controls, such as prohibitions against misbranding. Class II devices are those for which general controls are insufficient to ensure safety and effectiveness, and are therefore subject to certain “special controls” (such as post-market surveillance and development of product-specific guidelines). Class III devices present the greatest risk of injury and are therefore subject to a stringent “pre-market approval” process. FDA reviews which category is appropriate for a given device.
Class II devices can be marketed after the manufacturer establishes that the device is “substantially equivalent” to an already legally-marketed device, a process known as “510(k) clearance.” The statutes defining “substantial equivalence” require device manufacturers to show that the proposed device is as safe and effective as the legally-marketed device. As part of the 510(k) process, the FDA can require manufacturers to submit significant amounts of information, including proposed labels and data from clinical investigations. The vast majority of medical devices are currently brought to market through the 510(k) process.
The devices at issue in Hrymoc and McGinnis were Class II surgical mesh devices used to treat pelvic organ prolapse and stress urinary incontinence. Id. at *1–2. The plaintiffs in both cases suffered severe complications after their doctors surgically implanted the devices. Id. at *1. They filed suit against the manufacturers (Ethicon and C.R. Bard, Inc.), alleging various tort claims such as failure to warn and design defect. Id. Before each trial, the manufacturers sought to admit evidence that the FDA cleared their devices through the 510(k) process. Both trial courts refused and categorically excluded all such evidence from the liability and punitive damages phases. Id. at *9–10. In deciding to exclude the evidence, each trial court emphasized how the 510(k) substantial equivalency standard does not involve a determination of safety and effectiveness. Id. Additionally, the trial judge in McGinnis ruled that any probative value of the 510(k) evidence was substantially outweighed by prejudice and juror confusion (for instance, admission of such evidence could lead to a “mini-trial” about the process). Id. at *10–11.
The juries in each case found for the plaintiffs, awarding the Hrymoc plaintiff $5 million in compensatory damages and $10 million in punitive damages and awarding the McGinnis plaintiff $33 million in compensatory damages and $35 million in punitive damages. Id. at *1. The defendants appealed various issues, including the exclusion of 510(k) evidence.
The appellate court held that the “total disallowance” of evidence about the 510(k) process “had the patent capacity to deprive defendants of a fair trial, most poignantly with respect to the state-of-mind and venal conduct issues that underlie the punitive damages awards.” Id. The court’s reasoning focused on the balancing test under New Jersey Rule of Evidence 403. Although the appellate court agreed that the 510(k) process is “far less rigorous” than the pre-market approval process, the court reasoned that it “does provide evidence that a device manufacturer obtained regulatory authorization to market the product,” and that “evidence of such authorization does have probative value in evaluating the company’s design and sale of devices.” Id. at *14–15.
In addition to considering the relevance of 510(k) evidence, the appellate court emphasized how the evidentiary rulings “actually played out” in the two trials: the plaintiffs took “considerable advantage” of the exclusion of 510(k) evidence by repeatedly insinuating that clinical studies should have been required. Id. at *15. As the court pointed out, however, the manufacturers “should have been permitted” to counter those arguments with evidence about the 510(k) process “and the fact that the FDA did not require such clinical studies.” Id. The court further found that concerns over juror confusion or “mini-trials” could be addressed through a “well-crafted stipulation” and “cautionary instruction[s]” from the trial court. Id. at *16.
In holding that trial courts should not be allowed to ban 510(k) evidence categorically, the court acknowledged that the Fourth, Seventh, and Eleventh Circuit Courts of Appeals have upheld the exclusion of such evidence. Id. at *12–13. But the court also observed that a federal district court has ruled that 510(k) evidence should be admitted with appropriate limiting instructions. Id. at *13.
The appellate court’s decision is significant for several reasons. As stated above, before Hrymoc, several appellate courts had affirmed the exclusion of 510(k) evidence from trial. The Hrymoc decision gives manufacturers a precedential appellate decision to rely on in arguing such evidence should be admitted. Given that over 100,000 pelvic mesh cases have been filed in state and federal courts throughout the country, id. at *2, defendants can make immediate use of Hrymoc in litigating admissibility issues. Furthermore, the Hrymoc court’s analysis focused on the admissibility of 510(k) evidence under the general Rule 403 balancing test, which means that its reasoning extends beyond pelvic mesh cases in New Jersey to any instance where a court is weighing the admissibility of 510(k) evidence under the 403 standard.
Finally, Hrymoc is significant because most medical devices are brought to market pursuant to the 510(k) process. The court’s focus on how a “total ban on disclosure” of FDA evidence was not “fair or appropriate,” id. at *15, makes clear that trial courts should ensure a level playing field for device manufacturers, which includes permitting them to tell their side of the story with respect to the device’s development, approval, and marketing. Manufacturers should have confidence that using the most common FDA clearance process for medical devices will not put them at a disadvantage should they face a product liability suit related to their device.